BeVigilant™ OraFusion System Clinical Calibration and Classification Training Data Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Enhanced accuracy in referrals and early cancer detection leading to improved survival rates
研究概览
简要总结
This study aims to enhance the diagnostic capabilities of the OraFusion system by training algorithms to detect oral health biomarkers (EGFR and p16) linked to early stage oral cancer. The primary objective are to refine algorithm accuracy validate diagnostic classification across diverse patient groups amd assess the tool’s effectiveness in identifying pre-cancerous and cancerous conditions
Participants will provide saliva samples for analysis using the Ora- 3D platform which tests for biomarkers EGFR and p16. The system delivers rapid,real time results aiding in early cancer detection and improving patient referral accuracy. High risk participants will be referred for further diagnostic procedures such as biopsy.
Statistical analyses including logistic regression and sensitivity analysis will ensure robust evaluation and data integrity throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 22.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 22 years or older.
- •Presence of visible oral abnormalities such as leukoplakia erythroplakia or other lesions suggestive of early-stage oral cancer Ability and willingness to provide informed consent, saliva samples, and complete questionnaires Self-reported cancer-free status (no prior history of oral cancer) Demonstrated ability to participate in the study procedures including follow-up visits.
排除标准
- •Known history of oral cancer or other head and neck cancers Presence of conditions that could interfere with the collection or analysis of saliva samples (e g active oral infections severe dry mouth etc) Pregnant or lactating women Inability or unwillingness to provide informed consent or participate in follow-up procedures.
结局指标
主要结局
Enhanced accuracy in referrals and early cancer detection leading to improved survival rates
时间窗: 6 months
次要结局
- A sense of urgency for clinicians & patients to address high-risk cases promptly
- Streamlined processes for both patients & healthcare providers improving efficiency & reducing wait times
- Increased peace of mind for patients & clinicians especially when the care pathway is unclear
- A point-of-care device that provides near-instant results (approximately 10 minutes) empowering clinicians with timely decision-making(Day 0 (First Use): Record time between sample collection & clinical decision-making)
研究者
Ashok Dhoble
Indian Dental Association